Clinical trials: Total Neoadjuvant Therapy
Locally Advanced Rectal Cancer (LARC), Mismatch Repair-Proficient (pMMR) Rectal Cancer
QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer
This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4…
- Conditions
- Locally Advanced Rectal Cancer (LARC), Mismatch Repair-Proficient (pMMR) Rectal Cancer, Non-metastatic Rectal Cancer
- Trial name
- NCT07175636
- Testing
- Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT)
- Volunteers
- 66 people
- Sponsor
- Sun Yat-sen University
Rectal Neoplasms, Rectal Adenocarcinoma
A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in…
- Trial name
- NCT07543848
- Testing
- Serplulimab, Oncolytic Virus H101, XELOX Chemotherapy
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chongqing University Cancer Hospital
Locally Advanced Rectal Cancer
A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer
In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for…
- Trial name
- NCT07527026
- Testing
- Camrelizumab
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Chinese PLA General Hospital
Rectal Cancer, Rectal Cancer Stage II
TNT to Increase the Clinical Complete Response Rate for Distal LARC
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
- Conditions
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III, Chemoradiation
- Trial name
- TESS (NCT03840239)
- Testing
- Capecitabine, Oxaliplatin, External beam radiotherapy, Surgery
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Sun Yat-sen University
Rectal Cancer
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer.
- Trial name
- NCT06229041
- Testing
- Camrelizumab ＋Immunotherapy
- Where
- China
- Volunteers
- 472 people
- Sponsor
- Peking University Cancer Hospital & Institute
Colorectal Neoplasms
Brazilian Total Neoadjuvant Therapy Trial
Standard therapy for localized rectal cancer includes chemotherapy and radiation therapy, followed by a "recovery" period of 7-12 weeks, surgery and adjuvant chemotherapy for 3-6 months.
- Trial name
- BRAZIL-TNT (NCT05081687)
- Testing
- Folfirinox
- Where
- Brazil
- Volunteers
- 150 people
- Sponsor
- Hospital Israelita Albert Einstein
Rectal Cancer
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
- Trial name
- NCT06210971
- Testing
- liposomal irinotecan, Capecitabine, Radiation threapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital
Rectal Cancer, Adenocarcinoma
SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer.
- Trial name
- NCT07474103
- Testing
- SCRT, Liposomal Irinotecan, Oxaliplatin
- Where
- China
- Volunteers
- 49 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Rectal Cancer
Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in High-risk Rectal Cancer
Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative…
- Trial name
- LARCT-US (NCT03729687)
- Testing
- radiotherapy, capecitabine, oxaliplatin
- Where
- Sweden
- Volunteers
- 280 people
- Sponsor
- Uppsala University
Locally Advanced Rectal Cancer
SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is…
- Trial name
- SMART TNT (NCT05412082)
- Testing
- Intensity-modulated radiation therapy, 5-fluorouracil, Leucovorin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Miami
Rectal Cancer
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
Several trials showed that total neoadjuvant treatment (TNT) in stage II/III rectal cancer patients had better outcomes when compared with standard neoadjuvant long-course radiotherapy (CRT).
- Trial name
- NCT07095439
- Testing
- Total Neoadjuvant Treatment
- Where
- Egypt
- Volunteers
- 38 people
- Sponsor
- Ain Shams University
Rectal Cancer
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
- Trial name
- TNT-RECORD (NCT05883800)
- Testing
- On-couch adaptive radiotherapy
- Where
- Norway
- Volunteers
- 61 people
- Sponsor
- Haukeland University Hospital
Locally Advanced Rectal Cancer
Gut Microbiome and Its Immune Modulation in Locally Advanced Rectal Cancer
To investigate dynamic change of gut microbiomes and metabolites, and their effects on immune modulation. To evaluate the efficacy and safety of TNT with GEN-001 (Lactococcus lactis) and identify predictive biomarkers for…
- Trial name
- NCT05079503
- Testing
- GEN-001
- Volunteers
- 40 people
- Sponsor
- Korean Cancer Study Group
Locally Advanced Rectal Cancer
Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.
- Trial name
- ShorTrip (NCT05253846)
- Testing
- Irinotecan, Oxaliplatin, Lederfolin
- Where
- Italy
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gruppo Oncologico del Nord-Ovest
Borderline Resectable Pancreatic Cancer
IORT on Borderline Resectable Pancreatic Cancer
This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and…
- Trial name
- PancFORT (NCT04090463)
- Testing
- Intraoperative radiotherapy
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Universita di Verona